CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol

Denice S. Feig, Elizabeth Asztalos, Rosa Corcoy, Alberto De Leiva, Lois Donovan, Moshe Hod, Lois Jovanovic, Erin Keely, Craig Kollman, Ruth McManus, Kellie Murphy, Katrina Ruedy, J. Johanna Sanchez, George Tomlinson, Helen R. Murphy, CONCEPTT Collaborative Group, Stephanie Amiel, Katharine Hunt, Louisa Green, Benedetta RossiHelen Rogers, Ben Stodhart, Matteo Bonomo, Federico Bertuzzi, Giuseppina D. Corica, Silvana Fazio, Roberto Giro, Elena Mion, Andrea Moletta, Basilio Pintaudi, Rosa Sorrentino, Denice Feig, Barbara Cleave, Diane Donat, Shital Gandhi, Michelle Strom, Ana Isabel Chico, M. José Martínez, Mireia Sánchez, Diana Tundidor, John Booth, Natalia McInnes, Adelle Nykamp, Rose Otto, Ada Smith, Irene Stanton, Tracy Tazzeo, Lois E. Donovan, Carolyn Oldford, Catherine Young, Claire Gougeon, Robyn Houlden, Adriana Breen, Kristin Castorino, Erin Keely, Heather Clark, Laura Gaudet, Alan Karovitch, Janine Malcolm, Julia Lowe, Anna Rogowsky, Ruth McManus, Anne Kudirka, Margaret Watson, Damian Morris, Frances Farnworth, Duncan Fowler, Sue Mitchell, Josephine Rosier, Helen Murphy, Caroline Byrne, Katy Davenport, Jeannie Grisoni, Sandra Mulrennan, Sandra Neoh, Esther O'Sullivan, David Simmons, Zoe Stewart, Heike Templin, Helen Murphy, Jeremy Turner, Gioia Canciani, Niranjala Hewapathirana, Louise Jones, Leanne Piper, Rosemary Temple, Tara Wallace, Rahat Maitland, Anita Banerjee, Annette Briley, Anna Brackenridge, Pam Gilby, Carolyn Gill, Anna Reid, Claire Singh, Sara White, Maria Wolfs, Eleanor Scott, Del Endersby, Michael Maresh, Gretta Kearney, Juliet Morris, Susan Quinn, Prasanna Rao-Balakrishna, Malcolm MacDougall, Rudy Bilous, Mary Bilous, Shilpa Mahadissu, Deepika Menini, Rasha Mukhtar, Richard Holt, Jane Forbes, Nicki Martin, Fiona Walbridge, Peter Mansell, Gayna Babington, George Bugg, Tasso Gazis, Nia Jones, Dawn Spick, Simon Heller, Rebecca Bustani, Val Gordon, Priya Madhuvrata, Sue Hudson, Chloe Nisbet, Peter Novodvorsky, Alexandra Solomon, Karen Towse, Sam Philip, Anne Booth, Ann Cadzow, Martyna Chlost, Lynne Murray, Karen Norris, Katrina Shearer, Anna Dover, Frances Dougherty, Susan Johnston, Jill Little, Liz McKay, Robert Lindsay, David Carty, Isobel Crawford, Fiona Mackenzie, Therese McSorley, Fidelma Dunne, Elizabeth Brosnan, Sharon Conway, Michelle Courcy Byrnes, Linda Duane, Niamh Duffy, Aoife Egan, Geraldine Gaffney, Grainne Higgins, Caroline Kelly, Collette Kirwan, Aaron Liew, Kevin Normoyle, Christina Roarty, Mairead Waldron, John Weisnagel, Christyne Allen, Martin D'Amours, Marie Christine Dubé, Valérie Eve Julien, Ariane Godbout, Sylvie Daigle, Thomas Ransom, Jill Coolen, Darlene Baxendale, Jill Newstead-Angel, Alexandra L. Soloman, Karen Gorton, Margaret Jackson, Kirsty Miller, Julie Taylor, Asma Qureshi, Adriana Rodriguez, Kathryn Mangoff

Research output: Contribution to journalArticlepeer-review

21 Citations (Scopus)

Abstract

Background: Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes. For most women, optimal glycemic control is challenging to achieve and maintain. The aim of this study is to determine whether the use of real-time continuous glucose monitoring (RT-CGM) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy. Methods/design: A multi-center, open label, randomized, controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % (53 to ≤ 86 mmol/mol) or are in early pregnancy (<13 weeks 6 days) with an HbA1c of 6.5 % to ≤10.0 % (48 to ≤ 86 mmol/mol). Participants will be randomized to either RT-CGM alongside conventional intermittent home glucose monitoring (HGM), or HGM alone. Eligible women will wear a CGM which does not display the glucose result for 6 days during the run-in phase. To be eligible for randomization, a minimum of 4 HGM measurements per day and a minimum of 96 hours total with 24 hours overnight (11 pm-7 am) of CGM glucose values are required. Those meeting these criteria are randomized to RT- CGM or HGM. A total of 324 women will be recruited (110 planning pregnancy, 214 pregnant). This takes into account 15 and 20 % attrition rates for the planning pregnancy and pregnant cohorts and will detect a clinically relevant 0.5 % difference between groups at 90 % power with 5 % significance. Randomization will stratify for type of insulin treatment (pump or multiple daily injections) and baseline HbA1c. Analyses will be performed according to intention to treat. The primary outcome is the change in glycemic control as measured by HbA1c from baseline to 24 weeks or conception in women planning pregnancy, and from baseline to 34 weeks gestation during pregnancy. Secondary outcomes include maternal hypoglycemia, CGM time in, above and below target (3.5-7.8 mmol/l), glucose variability measures, maternal and neonatal outcomes. Discussion: This will be the first international multicenter randomized controlled trial to evaluate the impact of RT- CGM before and during pregnancy in women with type 1 diabetes.


Original languageEnglish
Article number167
Number of pages8
JournalBMC Pregnancy and Childbirth
Volume16
DOIs
Publication statusPublished - 18 Jul 2016
Externally publishedYes

Keywords

  • Continuous glucose monitoring
  • Diabetes mellitus type 1
  • Preconception
  • Pregnancy
  • Randomized controlled trial

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